[IEEE-bhpjobs] Fwd: Urgent Announcement to Submit Comments by Nov 23rd to SQA's Task Force on FDA GLP Modernization

[Esther L]

---------- Forwarded message ----------
From: NCCSQA Communique <sqacommunique at sqa.org>
Date: Nov 9, 2007 5:30 PM
Subject: Urgent Announcement to All NCCSQA Members (you do NOT need to
be a SQA member) to Submit Comments by Nov 23rd to SQA's Task Force on
FDA GLP Modernization
To: estheraauw at gmail.com

Please DO NOT reply to this e-mail.  You may reply to nccsqa_prog at yahoo.com


Dear NCCSQA Member:



SQA has formed a task force to participate in an initiative underway
at FDA. This is an important opportunity for SQA to leverage its
significant experience in the GLP regulatory environment to provide
input to FDA as the agency considers revisions to FDA the GLPs (Part
58).



The SQA Task Force is soliciting comments from its members.  Since
more than 50% of NCCSQA members do not belong to SQA, the NCCSQA Board
requested that ALL NCCSQA members be provided the opportunity to
comment as well.



Comments must be received by 23 November 2007 and may be submitted online at



http://www.surveymonkey.com/s.aspx?sm=DDRspjaGjR9BbJa8MRJ_2fJQ_3d_3d



Some areas in which we expect comments are in the areas of multi-site
studies, new technology and updated terminology, but feel free to
comment on other areas as well.  Be sure to relate any comments to the
most appropriate part of the FDA GLP regulation.



Task force participants from SQA represent various sectors of the
regulated community, e.g. independent consultants, sponsors, contract
research organizations, and academia, as well as a cross section of
SQA Specialty Sections.



Members of the Task Force are:

§    Nancy Gongliewski, Chair of the Task Force
SQA GLP Specialty Section Chair, Industry perspective (GlaxoSmithKline)

§    Matt Foster, RQAP-GLP
SQA FDA Liaison, CRO perspective (MPI Research)

§    Jim (James) Ault, RQAP-GLP, RAC
SQA Board member, CRO perspective (Ricerca Biosciences)

§    Debra Bridges, RVT, RQAP-GLP
SQA Med Devices Specialty Section – University perspective (Texas A&M)

§    Deborah Eyer Garvin, RQAP-GLP
SQA Past President, Consultant perspective (WCQTI/Pacific Rim Consulting Inc)

§    Tony (Anthony) Jones
SQA Regulatory Forum Chair, Bioanalytical CRO perspective (Taylor Technology)

§    Patricia O'Brien Pomerleau, RQAP-GLP
SQA Past President, CRO perspective (The Hamner Institutes, formerly CIIT)

§    John Yergler, RQAP-GLP
SQA Past President, Industry and Consultant perspective (Eli Lilly,
Consultant)



Barbara Foy and Jim McCormack are participating as SQA Board sponsors
of the committee.



Please participate by submitting your comments via the survey web link
even if you are not a member of SQA.  FDA has asked SQA for input on
GLP modernization, and FDA set a submission deadline.



Stu Mertz, President, NCCSQA





You may unsubscribe to NCCSQA Member E-mails by e-mailing nccsqa at sqa.org




-- 
--- Esther L., estheraauw at gmail.com
"You can not inspect quality into the product; it is already there."
-W. Edwards Deming
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